Principal GCP Quality Assurance Auditor

Description:
• Precision for Medicine is a global precision medicine clinical research services organization.
• The Principal Quality Auditor provides senior oversight and subject matter expertise to quality and compliance activities.
• Essential functions include serving as a subject matter expert and supporting project teams during all stages of clinical studies.

Requirements: • 5 years of experience • Working knowledge of GCP/ICH guidelines and FDA regulations and standards • Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits. • Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative • Availability to travel up to 25% domestically and/or internationally • CRO, Pharmaceutical and/or Medical device experience preferred • QA certification preferred (e.g., CQA, SQA, etc.) • Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

Benefits:
• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation

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